- OZOBAX is the first FDA-approved oral liquid baclofen.1
- OZOBAX is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus and muscular rigidity.2
- OZOBAX may also be of some value in patients with spinal cord injuries and other spinal cord diseases.2
- OZOBAX is not approved for use in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
- OZOBAX contains 5 mg/5 mL baclofen. It is a clear, colorless solution with a pleasant grape aroma. OZOBAX must be kept refrigerated at 36ºF to 46ºF.
Limitations of Use: OZOBAX is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
What is baclofen?3
Baclofen is a skeletal muscle relaxant used to treat some types of spasticity associated with certain disorders along with associated pain, clonus, and muscular rigidity. Oral baclofen comes in two formulations: oral tablets, and oral liquid.
How OZOBAX works4
OZOBAX can block nerve impulses both before a signal is sent and on the receiving end of the signal transmission at neuromuscular junctions close to the spine. As a result, OZOBAX essentially decreases the readiness of a nerve cell or neural circuit to respond to a stimulus, leading to decreasing input to muscle fibers.
Efficacy of OZOBAX
- For OZOBAX, the peak plasma concentrations are achieved in about 45 minutes.5
- In Multiple Sclerosis, oral baclofen demonstrated significantly better efficacy than placebo at improving muscle tone. 55%-72% of patients experienced an improvement with baclofen compared with the 0%-17.4% of patients who were given placebo.6
- Other studies in MS patients also demonstrated better efficacy in reducing spasm frequency with baclofen (42%-72%) than with placebo (6.3%-16%).6
- U.S. Food & Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Accessed January 9, 2020.
- OZOBAX [prescribing information]. Athens, GA: Metacel Pharmaceuticals, LLC; 2019.
- BACLOFEN- baclofen tablet. Prescribing Information. Teva Pharmaceuticals USA, Inc. Revised: 12/2019. https://www.tevagenerics.com/product/baclofen-tablets-usp. Accessed Feb. 12, 2020
- Chang E., A Review of Spasticity Treatments: Pharmacological and Interventional Approaches. Crib Rev Phys RehabilMed. 2013; 25(1-2): 11–22. doi:10.1615/CritRevPhysRehabilMed.2013007945.
- OZOBAX (baclofen) oral solution Prescribing Information. Revised 09/2019. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208193s000lbl.pdf. Accessed Feb. 13, 2020.
- ERTZGAARD P, CAMPO C and CALABRESE A. EFFICACY AND SAFETY OF ORAL BACLOFEN IN THE MANAGEMENT OF SPASTICITY: A RATIONALE FOR INTRATHECAL BACLOFEN. J Rehabil Med 2017; 49: 193–203.